Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of care for control of SE when administered by intra-venous (IV) route. The investigators intend to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for intra-venous cannulation is not available. Alternate routes of administration, if shown equivalent to conventional IV route, will be very useful in such settings or for out of hospital management of seizures in children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Intra-nasal 0.1 mg/kg (maximum 4 mg) once
Intra-venous 0.1 mg/kg (maximum 4 mg) once
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Cessation of all clinical seizure activity within 10 min of drug administration
Time frame: 10 min
Persistent cessation of seizure activity for 1 hr
Time frame: 1 hr
Patients requiring rescue medication within 1 hr
Time frame: 1 hr
Time to achieve intra-venous access after arrival in casualty
Time frame: minutes
Time from drug administration to termination of seizure(s)
Time frame: minutes
Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration
Time frame: 1 hr
Development of significant respiratory depression requiring assisted ventilation
Time frame: 1 hr
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